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Alcami RTP Expansion Nears Completion

MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing organization (CDMO), is pleased to announce that its 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month. This brand-new site with state-of-the-art design and controls became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services.  Specific investment has been made to offer industry-leading environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.

Topics: News & Events Blogs

505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). A 505(b)(2) application is a hybrid between the FDA's traditional NDA and an abbreviated new drug application (ANDA). These submission types were made possible in 1984 by the adoption of the Hatch-Waxman Act. The act was created to allow for generic competition and increased innovation in the pharmaceutical arena. A true generic or ANDA demonstrates that the drug is identical to an already approved product based on bioequivalence data and chemical equivalence. 

Topics: News & Events Regulatory Compliance Blogs 505(b)(2)

Roundtable Discussion with Pharma's Almanac: Greatest Drug Molecules to Impact Society & the Pharmaceutical Industry

Q: What two or three drug molecules do you identify as having had the greatest impact on society? What about on the pharmaceutical industry?

Over the last century, several groundbreaking inventions in drug discovery have contributed to a remarkable increase in life expectancy. Against this backdrop, it is difficult to identify three drugs having had the greatest impact on society. I’ve identified three that changed the course of medicine.

Insulin: The discovery of insulin revolutionized both the therapy and prognosis of diabetes. This is one of the most studied diseases in the history of medicine, dating back to Egyptian medical texts in 1552 BC. Ever since the isolation of insulin from pancreas tissue in 1923, numerous efforts were made to produce fully synthetic insulin, from rDNA human insulin in 1978 to various insulin analogs in 1996, aimed at optimizing the insulin absorption, distribution, metabolism, and elimination. The dream someday is for a needle-free delivery of insulin by oral route.

Topics: News & Events Editorials Blogs

Reducing Risk with Abuse‑Deterrent Formulations

Excerpted from Pharmaceutical Technology's editorial titled, "Reducing Risk with Abuse‑Deterrent Formulations."

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Possibly the most publicized and well-documented form of drug misuse and abuse has been that of opioids—prescription pain-relief medicines. The opioid crisis, which has impacted the global health community for several years, has paved the way for increased demand in abuse-deterrent formulations.

Abuse-deterrent formulations essentially have the potential to provide an effective way of reducing the capabilities of an end-user to abuse or misuse a medical therapy, while maintaining the drug’s clinical benefit. To explore the topic of abuse-deterrent formulations in more detail, Pharmaceutical Technology spoke with Angela Moore, scientist, Analytical Development, Alcami.

Topics: News & Events Abuse-Deterrence Editorials Blogs

Alcami Appoints Walter J. Kaczmarek III as Chief Executive Officer

Alcami announced today the appointment of Walter J. Kaczmarek III as Chief Executive Officer. Mr. Kaczmarek, who has over 30 years of experience in the pharmaceutical industry, will focus on advancing Alcami's next phase of strategic growth. 

Mr. Kaczmarek has served in executive roles at multiple pharmaceutical companies, including as President of the Multisource Pharmaceuticals division of Mallinckrodt Pharmaceuticals, COO of Aceto Corporation, and most recently, as President and CEO of Cosette Pharmaceuticals Inc. Mr. Kaczmarek is an industry veteran with a depth of experience spanning the entire value chain from development and manufacturing to sales and marketing.

Topics: News & Events Blogs

Alcami Continues to Strengthen Senior Leadership Team with Appointment of Quality and Regulatory Leaders

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced further additions to strengthen its senior leadership team. Brian Dillion has been appointed to the role of Vice President of Regulatory Affairs and Quality Assurance and Jacquelyn Uribe has been appointed to the role of Vice President of Quality Operations. “Jacque and Brian bring broad compliance expertise with a track record of success upholding the rigorous standards required by both customers and regulators in high growth environments,” commented Chief Financial Officer Eric Evans.

Topics: News & Events Blogs

Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Ken Domagalski and Elliott Franco to their Senior Leadership Team. Ken Domagalski has been appointed to the role of Executive Vice President of Drug Product Operations and Elliott Franco has been appointed to the role of Vice President of Laboratory Operations.

Topics: News & Events Blogs

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

Topics: News & Events Editorials Parenteral Manufacturing Blogs

Alcami Announces Senior Leadership Appointments

WILMINGTON, NC – May 8, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Sally Langa and Kimberly McClintock to their Senior Leadership team. Sally Langa has been appointed to the role of Senior Vice President of Sales and Kimberly McClintock has been appointed to the role of Vice President of Marketing and Client Services.  

Topics: News & Events Blogs

Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Topics: Regulatory Compliance Drug Product Orphan Drugs Blogs